MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	CQ5072
Medical Device Problem Codes	Material Frayed (1262); Peeled/Delaminated (1454); Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device was returned to bd for evaluation.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction event.A review of the events indicated that model cq5072 pta balloon dilatation catheter experienced frayed material, a peeled outer layer, and unraveled material.This report was received from one source.This event involved one patient with no patient consequences.The patient was a (b)(6) year old male, weighing (b)(6) pounds.
Additional Manufacturer Narrative
H10: of the one device, lot number was provided, and lot history review was performed.Peeled pebax and frayed fibers was identified.A root cause has not been determined.The device was labeled for single use.H10: g4 h11: h6 ( results, conclusion) h11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
This report summarizes one malfunction event.A review of the events indicated that model cq5072 pta balloon dilatation catheter experienced frayed material, a peeled outer layer, and unraveled material.This report was received from one source.This event involved one patient with no patient consequences.The patient was a 61 year old male, weighing 197 pounds.

• Brand Name: CONQUEST PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8515481
• Report Number: 2020394-2019-00299
• Device Sequence Number: 1922229
• Product Code: DQY
• UDI-Device Identifier: 00801741062940
• UDI-Public: (01)00801741062940
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: CQ5072
• Device Catalogue Number: CQ5072
• Device Lot Number: RECP0904
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1